Abstract: A sheath lock for use with a splittable sheath is disclosed. The sheath lock includes a tapered slot extending from a wide untapered end to a narrow tapered end. A lock box is located adjacent the narrow tapered end of the tapered slot. The lock box has a plurality of tines which grip and retain the sheath when it is positioned within the lock box. The sheath can freely move through the wide untapered end, but the sheath is securely locked when it is moved through the tapered slot from the untapered end into the lock box. The plurality of tines can be arranged in various configurations to form the lock box, including elliptical, circular, rectangular or square configurations around the lock box.

Abstract: A blood seal having a spring-biased septum is provided for preventing the leakage of blood during the placement and use of vascular catheters and similar devices. The structure of the blood seal includes a housing with an internal channel. A spring-biased septum is placed securely within the channel such that it substantially blocks blood flow through the channel. The spring-biased septum includes an elastic plug having a pre-slit or pre-molded hole and a biasing element disposed about the elastic plug. A needle or other object may be withdrawn through the slit or hole, after which the biasing element forces the hole closed, preventing blood leakage.

Abstract: A catheter and introducer needle assembly with a compact needle shield is provide. The introducer needle includes an enlarged diameter portion. The needle shield is disposed inside the catheter hub. The needle shield includes a transverse barrier to prevent unwanted distal movement of the needle once the needle has been withdrawn into the needle shield. The needle shield also includes a small diameter proximal opening to limit proximal movement of the needle out of the needle shield.

Abstract: A needle retraction mechanism includes a hollow handle defining a cavity, a needle hub assembly movably disposed in the handle, a biasing mechanism to move the needle hub assembly from an extended position to a retracted position and a latch to hold needle hub assembly in the extended position against the bias of the biasing mechanism. The needle hub assembly includes a flexible stopper at its proximal end that creates an air tight seal with the inner wall of the handle. This allows a vacuum to be created between the proximal end of the handle and the flexible stopper when the needle hub is moved from the retracted position to the extended position. The configuration of the flexible stopper allows it to change the amount of frictional force created between the inner wall of the handle and the flexible stopper when the device is at different elevations.

Abstract: The present invention is directed to a vascular access device for introducing a catheter in a blood vessel using a guide advancing mechanism. The device generally comprises a housing, an introducer needle, a catheter, a guide wire and an actuating means. The introducer needle of the vascular access device is used to penetrate the blood vessel. The actuating means is then initiated and the guide wire is steadily propelled into the blood vessel. Once the guide wire is in place, the catheter, which is concentrically placed over the introducer needle and guide wire, is uncoupled from the vascular access device and guided into the blood vessel by the guide wire.

Abstract: The medical site prep device of this invention includes a main body portion, preferably in the shape of a hollow ring, a sponge-like material attached to the bottom of the main body portion, a plate disposed in the center of the main body portion and a piston disposed above the plate in the center of the main body portion. The medical site prep device of this invention can simultaneously dispense an anti-microbial agent and a topical anesthetic at the medical site on a patient.

Abstract: A kit and for flushing a medical device a method of preparing the kit is disclosed. The kit includes a container containing a mixed solution a unit dose of a pharmacologically effective amount of an antimicrobial agent and a second agent. The mixed solution has been mixed in a carrier solution and lyophilized. The second agent is an anticoagulant, an antithrombotic agent or a chelating agent. The kit and method are useful for maintaining the patency of indwelling medical devices such as catheters and for preventing infections caused by bacterial growth in catheters.

Abstract: A method of forming a slit in a reseal element having an outer surface defined by a proximal end thereof, a semi-spherical inner surface portion defined by a dome region of the proximal end, and an annular inner surface portion which circumvents the semi-spherical inner surface portion. The method is accomplished through the use of a cutting assembly which includes a locator plate having a locator cavity disposed therein, a cutting core, a support fixture, and a blade member. The method comprises the initial step of inserting the reseal element into the locator cavity of the locator plate. Thereafter, the dome region of the reseal element is pre-stressed by the contact of the support fixture thereagainst, with the blade member then being advanced upwardly through the proximal end of the reseal element to form the slit therein.

Abstract: A solution of the present invention useful for flushing an intravascular catheter includes a pharmacologically acceptable sodium salt, a pharmacologically acceptable calcium salt, a pharmacologically acceptable potassium salt and about one milligram per milliliter polyhexamethylene biguanide hydrochloride in an aqueous admixture. Additionally, the solution of the invention may also contain a pharmacologically acceptable salt of lactic acid.

Abstract: A cannula that is usable to remove blood from a patient during an operation such as bypass surgery where the cannula has a pressure sensor in the form of an electronic piezoresistive chip located at or adjacent the location within the heart where the blood is being removed. The crystal has a sensing side and a reference side that is exposed to a reference pressure that is known. The piezoresistive chip is mounted at the distal end of the cannula such that its sensing side faces outwardly away from the central bore of the cannula that is transporting the blood that is being removed and thus is isolated from the dynamic effects of the moving blood. In addition, the pressure sensor has a characteristic drift based on temperature and the sensor is therefore standardized at body temperature, 36 degrees Centigrade, so that the pressure sensor is standardized at the temperature at which it will be used when positioned within the patient.

Abstract: A needleless injection site comprising a housing which defines an interior chamber and a central opening which communicates with the interior chamber. The housing further comprises an elongate, proximally extending dilator projection portion which defines a fluid passage. Disposed within the central opening and the interior chamber is a reseal member which has an elastically openable and closable aperture disposed therein and defines an expandable and collapsible internal reservoir. The reseal member normally resides in a first position within the housing wherein the aperture is in a closed configuration and the reservoir is collapsed. The reseal member is deformable such that the application of distally directed pressure thereto will cause the reseal member to distally advance within the housing to a second position wherein the aperture assumes an open configuration and communicates with the fluid passage and the reservoir.

Abstract: A disconnect device for placement in a medical tubing set of the present invention includes a first portion with a first passageway therethrough that has a first valve therein. While the first valve is biased in a normally closed position to close the first passageway, it is operative to an open position. The disconnect device of the invention has a second portion with a second passageway therethrough that has a second valve therein. The second valve is also biased in a normally closed position to close the second passageway and it also is operative to an open position. The second portion is releasably attached to the first portion, connecting the first and second passageways in fluid communication, to overcome the bias of the first valve and the second valve, to open the valves and to allow a fluid flow through the device.

Abstract: A winged catheter introducer for use in introducing a catheter into a blood vessel is disclosed. A needle is disposed within the catheter to help penetrate a patient's blood vessel. The needle and catheter are disposed within an introducer body having a pair of deformable wings extending from opposite sides of the body. A pair of opposing clamp jaws are disposed within the introducer body adjacent the wings. The clamp jaws are configured to grip and retain the catheter and needle when the wings are compressed towards each other. In a disclosed embodiment, the clamp jaws are biased in an open configuration and define clamp surfaces having angled ridges which engage the catheter exterior surface.

Abstract: This invention relates to the use of vitamin E or its derivative, such as vitamin E acetate, with a silicone lubricant for use on a medical device. The vitamin E prevents degradation of the silicone lubricant when the medical device is irradiated for sterilization.

Abstract: An eccentric rotary high pressure seal is disclosed herein. This seal includes a valve body and a spring located in a housing. The spring biases the valve body to rotate. The valve body defines a longitudinally extending passage having dimensions sufficient to allow an introducer needle to pass there through. This passage is offset from the axis of the valve body. The valve body is located in a housing that will allow the valve body to rotate therein. The housing defines two longitudinally aligned openings that are offset from the axis of the housing. These two longitudinally aligned openings are oriented such that the passage in the valve body can be aligned with the openings located in the housing. In this manner, an introducer needle can extend into the housing and hold the valve body against the bias of the spring. Once the introducer needle is removed from the housing, the valve body is no longer held in place against the force of the spring.

Abstract: Devices and methods for slowing down or dampening the retraction velocity of an introducer needle used in connection with needle retracting safety vascular access devices. The devices and methods prevent splattering or dripping of blood caused by an introducer needle that retracts too quickly. The dampening devices can be easily modified to regulate the amount of dampening desired and can be retrofitted to existing vascular access devices designs.

Abstract: A needle retraction mechanism includes a hollow handle defining a cavity, a tab associated with the handle, a needle hub assembly movably disposed in the handle, a biasing mechanism to move the needle hub assembly from an extended position to a retracted position and an arm to hold needle hub assembly in the extended position against the bias of the biasing mechanism. The tab and arm are configured such that downward movement of the tab engages the arm to allow the needle hub to move to the proximal end of the handle. In addition, the tab and arm are configured so that at least a portion of the downward movement of the tab is translated into a proximally directed axial movement of the needle hub This facilitates movement of the needle hub and overcomes any static friction between the needle hub and the inner wall of the handle tending to hold the needle hub in the extended position.

Abstract: This invention relates to a splittable medical device incorporating two sets of preferential tear lines. The first set of preferential tear lines preferably includes two longitudinally extending skives formed along the exterior surface of the proximal portion of the splittable medical device. The second set of preferential tear lines preferably includes a plurality of grooves formed along a distal portion of the interior portion of the splittable medical device. The skives should be substantially aligned with some of the grooves. This configuration facilitates splitting of the medical device along the skives and along one or more of the grooves to allow a clinician to split the medical device completely into two pieces. This invention includes a special mandrel having a plurality of ribs formed along a distal portion thereof and process that is used to manufacture the splittable medical device.

Abstract: The lubricant of this invention is a combination of a PLURONIC.RTM. polyol and a phospholipid. The lubricant is applied to the surface to be lubricated by forming a solution of water and the lubricant. This solution may also include Vitamin E or its derivative. In addition, a solution stabilizer and an antimicrobial agent may be used to clarify the solution and to inhibit microbial growth in the solution.